Access port identification systems and methods

ABSTRACT

An access port for subcutaneous implantation is disclosed. Such an access port may comprise a body for capturing a septum for repeatedly inserting a needle therethrough into a cavity defined within the body. Further, the access port may include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. Further, the subcutaneously implanted access port may be identified in response to perceiving the at least one feature. In one embodiment, an identification feature is engraved or otherwise defined by the access port, so as to be visible after implantation via x-ray imaging technology.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/420,028, filed Apr. 7, 2009, now U.S. Pat. No. 7,947,022, which is acontinuation-in-part of U.S. application Ser. No. 11/368,954, filed Mar.6, 2006, now U.S. Pat. No. 7,785,302, which claims the benefit of U.S.Provisional Application No. 60/658,518, filed Mar. 4, 2005. Each of theafore-referenced applications is incorporated, in its entirety, by thisreference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a perspective view of an embodiment of an access portaccording to the instant disclosure;

FIG. 1B shows a schematic side cross-sectional view the access portshown in FIG. 1A;

FIG. 2 shows a perspective view of an embodiment of an access portaccording to the instant disclosure;

FIG. 3 shows a perspective view of an access port according to theinstant disclosure;

FIG. 4 shows a perspective view of an access port according to theinstant disclosure;

FIG. 5 shows a perspective view of an access port according to theinstant disclosure;

FIG. 6A shows a perspective view of an access port according to theinstant disclosure;

FIG. 6B shows a side view of the access port shown in FIG. 6A;

FIG. 7 shows a perspective view of an access port according to theinstant disclosure;

FIG. 8 shows a simplified perspective view of a cap for forming anaccess port according to the instant disclosure;

FIG. 9 shows a simplified perspective view of a cap for forming anaccess port according to the instant disclosure;

FIG. 10 shows a simplified perspective view of a cap for forming anaccess port according to the instant disclosure;

FIG. 11 shows a simplified perspective view of a cap for forming anaccess port according to the instant disclosure;

FIG. 12 shows a simplified perspective view of a cap for forming anaccess port according to the instant disclosure;

FIG. 13 shows a simplified perspective view of a cap for forming anaccess port according to the instant disclosure;

FIG. 14 shows a simplified perspective view of a cap for forming anaccess port according to the instant disclosure;

FIG. 15A shows a perspective view of an embodiment of an access portaccording to the instant disclosure;

FIG. 15B shows a top elevation view of the access port shown in FIG.15A;

FIG. 16 shows a perspective view of an access port according to theinstant disclosure;

FIG. 17 shows a perspective view of an access port according to theinstant disclosure;

FIG. 18 shows a perspective view of an access port according to theinstant disclosure;

FIG. 19 shows a perspective view of an access port according to theinstant disclosure;

FIG. 20 shows a perspective view of an access port according to theinstant disclosure;

FIG. 21 shows a perspective view of an access port according to theinstant disclosure;

FIG. 22 shows a perspective view of another embodiment of an access portaccording to the instant disclosure;

FIG. 23 shows a top elevation view of the assembled access port shown inFIG. 22;

FIG. 24 shows a simplified representation of a transverse cross sectionof the access port shown in FIGS. 22 and 23;

FIGS. 25-51 show perspective views of additional embodiments of anaccess port.

FIG. 52 shows a bottom perspective view of an access port according toone embodiment;

FIG. 53A shows a top view of the access port shown in FIG. 52;

FIG. 53B shows a bottom view of the access port shown in FIG. 52;

FIG. 54A represents a radiographic image of the access port shown inFIG. 52 when viewed from above the access port;

FIG. 54B represents a radiographic image of the access port shown inFIG. 52 when viewed at an angle of approximately 20 degrees;

FIG. 54C represents a radiographic image of the access port shown inFIG. 52 when viewed at an angle of approximately 50 degrees;

FIG. 55 shows a cross-sectional view of the access port shown in FIG.52;

FIGS. 56A and 56B show cross-sectional views of example embodiments ofengraved features on an access port surface;

FIG. 57A shows a top perspective view of an access port according to oneembodiment;

FIG. 57B shows a bottom perspective view of the access port shown inFIG. 57A;

FIG. 57C shows a bottom view of the access port shown in FIG. 57A;

FIG. 58A shows a top perspective view of another embodiment of an accessport;

FIG. 58B shows a bottom perspective view of the access port shown inFIG. 58A;

FIG. 58C shows a bottom view of the access port shown in FIG. 58A;

FIG. 59A shows a side view of an embodiment of an access port;

FIG. 59B shows a bottom view of the access port shown in FIG. 59A;

FIG. 60A shows a bottom perspective view of an additional embodiment ofan access port;

FIG. 60B shows a bottom view of the access port shown in FIG. 60A;

FIG. 61A shows a bottom perspective view of an additional embodiment ofan access port;

FIG. 61B shows a bottom view of the access port shown in FIG. 61A;

FIG. 62A shows a bottom view of an additional embodiment of an accessport;

FIG. 62B shows a side view of the access port shown in FIG. 62A;

FIG. 62C shows an end view of the access port shown in FIG. 62A;

FIG. 63A shows a bottom view of another embodiment of an access port;

FIG. 63B shows a side view of the access port shown in FIG. 63A; and

FIG. 63C shows an end view of the access port shown in FIG. 63A.

DETAILED DESCRIPTION

The instant disclosure relates generally to percutaneous access and,more specifically, to methods and devices associated with percutaneousaccess. Generally, the instant disclosure relates to an access port forsubcutaneous implantation. In one embodiment, an access port may allow aphysician or other medical personnel to obtain long term percutaneousaccess to the interior of a patient's body. Employing an access port forpercutaneous access may reduce the opportunity for infection byinhibiting fluid connections (that extend into the interior of apatient's body) from the patient's skin and from the externalenvironment. The access device allows access to the interior of thepatient without requiring a needle to pierce the skin. Further, internalcomponents, such as a catheter or a valve, may be replaced without asurgical procedure. Features or aspects of the instant disclosure mayapply to any such access ports for subcutaneous access to a patient,without limitation. The access port may be injected by hand (e.g., via asyringe including a needle) for example, or may be injected andpressurized by mechanical assistance (e.g., a so-called power injectableport).

Power injectable ports may be employed in, among other processes, forexample, computed tomography (“CT”) scanning processes. Moreparticularly, a so-called “power injector” system may be employed forinjecting contrast media into a peripherally inserted intravenous (IV)line. For example, such power injectors or injection systems may becommercially available from Medrad, Inc., a subsidiary of Schering AG,Germany and may be marketed under the trademark STELLANT®. Because fluidinfusion procedures are often defined in terms of a desired flow rate ofcontrast media, such power injection systems are, in general,controllable by selecting a desired flow rate.

More specifically, the instant disclosure relates to an access porthaving at least one perceivable or identifiable feature for identifyingthe access port, wherein the identifiable feature is perceivable afterthe access port is implanted within a patient. For example, at least oneor perhaps multiple identifiable feature(s) of an access portcontemplated by the instant disclosure may be correlative to information(e.g., a manufacturer's model or design) pertaining to the access port.Thus, an identifiable feature from an access port of a particular modelmay be unique in relation to most if not all other identifiable featuresof another access port of a different models or design. Of course, theat least one identifiable feature of an access port contemplated by theinstant disclosure may be further correlative with any information ofinterest, such as type of port, catheter type, date of manufacture,material lots, part numbers, etc. In one example, at least oneidentifiable feature of an access port may be correlative with theaccess port being power injectable. In this way, once at least oneidentifiable feature of an access port is observed or otherwisedetermined, correlation of such at least one feature of an access portmay be accomplished, and information pertaining to the access port maybe obtained.

In one embodiment, at least one feature may be perceived by palpation(i.e., to examine by touch), by way of other physical interaction, or byvisual observation. Accordingly, a person of interest may touch or feelthe access port through the skin to perceive at least one identifyingcharacteristic thereof. In another embodiment, at least one identifiablefeature may be perceived via x-ray or ultrasound imaging. In yet afurther embodiment, at least one identifiable feature may be perceivedthrough magnetic, light, or radio energy interaction or communicationwith the access port.

Turning to the embodiment wherein at least one feature may be perceivedthrough palpation, other physical interaction, or visual observation, atopography or exterior surface feature of an access port contemplated bythe instant disclosure may be configured for perception. For example,referring to FIGS. 1A and 1B, an exemplary access port 10 contemplatedby the instant disclosure is shown. FIGS. 1A and 1B show a perspectiveview and a schematic side cross-sectional view, respectively, of anaccess port 10 for allowing percutaneous or otherwise internal access toa patient's body. Access port 10 includes a housing or body 20 definedby a cap 14 and a base 16. Cap 14 and base 16, as known in the art, maybe configured for capturing therebetween a septum 18. As shown in FIG.1A, cap 14 and base 16 may matingly engage one another along a matingline 15. Cap 14 and base 16 may be secured or affixed to one another viamechanical fasteners such as screws or other fastening devices, may beadhesively affixed to one another, or may be affixed to one another asknown in the art. Further, cap 14, base 16, and septum 18 maycollectively define a cavity 36 in fluid communication with a lumen 29of outlet stem 31.

The body 20 may be implanted in a patient 7, as shown in FIG. 1B, todispose the cavity 36 subcutaneously within the patient 7. Also, sutureapertures 66 (FIG. 1A) may be used to affix the access port 10 withinthe patient 7, if desired. After the body 20 is implanted in a patient7, the upper surface of the septum 18 may be substantially flush withthe surface of the skin 6 of the patient 7 and may be repeatedlypunctured for creating a percutaneous passageway from the exterior ofthe skin of the patient into the cavity 36. The outlet stem 31 maycreate a fluid-communicative passageway from the cavity 36 through theoutlet stem 31 and into the interior of the patient 7. A catheter may becoupled to the outlet stem 31 for fluid communication with the cavity 36and for transferring fluid from the cavity 36 to a desired remotelocation from the cavity 36 and within a patient 7.

Body 20 of access port 10 may comprise a bio-compatible material such aspolysulfone, titanium, or any other suitably bio-compatible material asknown in the art. Accordingly, the body 20 may be formed from abio-compatible plastic material. If desired, the body 20 may comprise apenetrable material for penetration by sutures or needles. In anotherembodiment, and as discussed further hereinbelow, body 20 may comprisean impenetrable material such as, for instance, a metal if desired. Body20 may include a concave bottom or, in another embodiment, may include aflat bottom, without limitation.

According to the instant disclosure, access port 10 may comprise a body20 exhibiting at least one identifiable feature. More particularly, asshown in FIG. 1A, body 20 may exhibit a partial generally pyramidalshape (i.e., a polygonal base having surfaces for each side of thepolygon extending toward a common vertex otherwise known as a frustum).Generally, a body 20 of an access port 10 may exhibit a partialpyramidal shape extending between a generally quadrilateral shaped basepositioned at reference plane 11 and a generally quadrilateral shapedupper base positioned at reference plane 9. Reference planes 9 and 11will not be shown in FIGS. 2-21, for clarity; however, reference toplanes 9 or 11 with respect to FIGS. 2-21, as used herein, will refer tocorresponding reference planes analogous to reference planes 9 and 11 asshown in FIGS. 1A and 1B.

As shown in FIG. 1A, the exterior of access port 10 is substantiallydefined by four substantially planar side surfaces 50 connected to oneanother by radiuses 32. In addition, the upper topography 61 of accessport 10 is defined by upper surface 60 in combination with chamfers 46Aand 46B and may be further defined by the upper surface of septum 18.Explaining further, the outer periphery of upper topography 61 may bedescribed as a generally quadrilateral exterior formed by side regions54 and having rounded corner regions 30 adjacent side regions 54. Such aconfiguration may provide an access port having at least one featurethat may be perceived by palpation.

It may be appreciated that there are many variations to the geometry ofaccess port 10 as shown in FIG. 1A. For instance, while the body 20 ofaccess port 10 may be described as a partially pyramidal shape orfrustum, the instant disclosure is not so limited. Rather, one or moreof side surfaces 50 may be oriented at as may be desired, withoutreference to any other side surfaces 50. Accordingly, for example, oneof surfaces 50 may be substantially vertical while the remainingsurfaces 50 may be oriented at respective, selected angles. Furthermore,it should be understood that FIG. 1A is merely exemplary and that thedimensions and shape as shown in FIG. 1A may vary substantially whilestill being encompassed by the instant disclosure.

FIG. 2 shows a perspective view of another embodiment of access port 10according to the instant disclosure. As shown in FIG. 2, the exterior ofaccess port 10 is substantially defined by a generallyparallelogram-shaped base (positioned at reference plane 11 as shown inFIGS. 1A and 1B) extending generally pyramidally to a generallyparallelogram-shaped upper surface (positioned at reference plane 9 asshown in FIGS. 1A and 1B). As shown in FIG. 2, radiuses 42 may be largerthan radiuses 32 as shown in FIG. 1A. Furthermore, the upper topography61 of access port 10 as shown in FIG. 2 may include rounded cornerregions 40 which are larger than rounded corner regions 30 as shown inFIG. 1A. Thus, FIG. 2 shows an exemplary embodiment of an access port 10that may be perceivably distinguishable from access port 10 as shown inFIGS. 1A and 1B. For example, a difference between one exterior of anaccess port contemplated by the instant disclosure and another exteriorof a different access port contemplated by the instant disclosure may bedetermined by way of palpation.

In another embodiment, in another aspect contemplated by the instantdisclosure, a template may be employed for perceiving at least onefeature of an access port. For instance, a complementarily-shapedtemplate may be positioned over and abutted against an access portcontemplated by the instant disclosure so as to determine if the accessport matches or substantially corresponds to the shape of the template.Such a process may reliably indicate or perceive at least one feature ofan access port contemplated by the instant disclosure. Of course, aplurality of templates corresponding to different models of access portsmay be serially engaged with an unknown access port so as to perceive atleast one feature thereof. Such a process may allow for identification(e.g., of a model or manufacturer) of an access port contemplated by theinstant disclosure.

In another aspect contemplated by the instant disclosure, an uppertopography of an access port may include at least one feature foridentifying the access port. For example, as shown in FIG. 3, uppersurface 60 of access port 10 may be nonplanar. More specifically, uppersurface 60 may be tapered or may arcuately extend downwardly (i.e.,toward reference plane 11 as shown in FIGS. 1A and 1B) as it extendsradially inwardly toward septum 18. Otherwise, access port 10, as shownin FIG. 3, may be configured substantially as described hereinabove withreference to FIGS. 1A and 1B. Thus, upper surface 60 is one exemplaryexample of at least one perceivable feature for identification of anaccess port contemplated by the instant disclosure.

In yet a further embodiment of an access port contemplated by theinstant disclosure, side regions 54 extending between rounded cornerregions 30 may exhibit at least one perceivable feature. For example, asshown in FIG. 4, access port 10 may include one or more side regions 54that extend arcuately between adjacent rounded corner regions 30.Otherwise, access port 10, as shown in FIG. 4, may be configuredsubstantially as described hereinabove with reference to FIGS. 1A and1B. Side regions 54 may be congruent or symmetric with respect to oneanother or, in another embodiment, may be configured differently withrespect to one another, without limitation.

FIG. 5 shows a further exemplary embodiment of an access portcontemplated by the instant disclosure. More specifically, access port10, as shown in FIG. 5, includes side regions 54 that form recessedregions 72 between adjacent rounded corner regions 30. Put another way,the upper topography 61 may include alternating recessed regions 72 andprotruding regions 70 positioned generally about a periphery of septum18. Otherwise, access port 10, as shown in FIG. 5, may be configuredsubstantially as described hereinabove with reference to FIGS. 1A and1B. Such a configuration may provide an access port having at least oneidentifiable feature.

In a further embodiment of an access port contemplated by the instantdisclosure, FIGS. 6A and 6B show a perspective view and a side view,respectively, of an access port 10 generally configured as is describedwith reference to FIG. 5 but having an elongated body 20E. Morespecifically, elongated body 20E of access port 10, as shown in FIGS. 6Aand 6B, includes a side surface 50E that extends generally from uppertopography 61 downwardly (i.e., toward reference plane 11 as shown inFIGS. 1A and 1B) and having a slope (e.g., an angle with respect to avertical axis normal to an upper surface of septum 18) which isdifferent from the other side surfaces 50. Otherwise, access port 10, asshown in FIG. 6, may be configured substantially as describedhereinabove with reference to FIGS. 1A and 1B. Such a configuration mayprovide an elongated body 20E of an access port 10 having an elongatedside portion.

Of course, one or more side surfaces of an access port according to theinstant disclosure may be configured for forming a body exhibiting aselected shape as may be desired. An elongated body portion of an accessport contemplated by the instant disclosure may form, in combinationwith other features as described hereinabove or, in another embodiment,taken alone, at least one perceivable feature for identification of anaccess port according to the instant disclosure.

FIG. 7 shows a further embodiment of an access port encompassed by theinstant disclosure. Particularly, as shown in FIG. 7, access port 10 mayinclude an upper body portion 20 a and a lower body portion 20 b.Furthermore, each of upper body portion 20 a and lower body portion 20 bmay exhibit a partial pyramidal shape (i.e., a frustum), wherein thebody portions 20 a and 20 b are stacked vertically with respect to oneanother. Accordingly, upper body portion 20 a may form an overhangingrim feature 76 extending along a periphery of access port 10. Explainingfurther, lower body portion 20 b may have an exterior substantiallydefined by side surfaces 50 b and rounded corner regions 30 b, whileupper body portion 20 a may have an exterior substantially defined byside surfaces 50 a, rounded corner regions 30 a, and upper topography61. It may be appreciated that overhanging rim feature 76 may be sizedand configured for perception via palpation. Such a configuration mayprovide a suitable access port for delivery of a beneficial or medicinalsubstance, the access port being identifiable (e.g., by model number,manufacturer, etc.) after implantation.

It should be understood that the instant disclosure contemplates accessports having an exterior geometry that is not quadrilateral in nature.Rather, the instant disclosure contemplates that an access port may havean exterior which is generally cylindrical, generally conical, generallyelliptical, generally oval, or an exterior that is otherwise arcuate innature. Specifically, the instant disclosure contemplates that an accessport having a substantially rounded or arcuate exterior may include atleast one feature configured for identification of the access port afterimplantation. For example, as shown in FIG. 8, shows a cap 14 thatexhibits an exterior surface 78 that is substantially conical. Cap 14may be assembled to a suitable base (not shown) for capturing a septum(not shown) as described hereinabove to form an access port 10 asgenerally described with reference to FIGS. 1-7.

The instant disclosure further contemplates that at least oneprotrusion, protruding region, recess, recessed region, undulation, oradjacent features of different elevation may comprise a feature foridentifying an access port contemplated by the instant disclosure. Morespecifically, upper topography 61C, as shown in FIG. 8, may include aplurality of protrusions 80. Protrusions 80 may exhibit partiallyspherical upper surfaces that transition into a lower portion of cap 14.In further detail, protrusions 80 may be circumferentially spaced aboutthe periphery of septum (not shown) as may be desired. In oneembodiment, a plurality of protrusions 80 may be symmetricallycircumferentially spaced about the periphery of septum (not shown). Moregenerally, at least one protrusion 80 may be sized, configured, andpositioned for forming at least one identifiable feature of an accessport. Of course, at least one protrusion 80 may be structured forfacilitating comfort of a patient within which the access port isimplanted. As may be appreciated, at least one protrusion 80 or morethan one protrusion 80 may be included in an upper topography 61C of anaccess port (not shown) contemplated by the instant disclosure.

FIG. 9 shows another embodiment of a cap 14 including at least oneprotrusion 80E for forming and identifying an access port contemplatedby the instant disclosure after implantation thereof within a patient.Protrusions 80E may extend circumferentially about a center ofrevolution. Thus, protrusions 80E may exhibit a body 87 portioncircumferentially extending between rounded ends 83. Further, cap 14 mayhave an exterior surface 78 that is substantially symmetric about anaxis of revolution. More generally, body 20 may extend from a generallycircular, generally elliptical, or generally oval base positioned at alower extent 71 of the cap 14 to an upper generally circular, generallyelliptical, or generally oval cross section that is smaller than a crosssection of the base and is positioned at an upper extent 73 (withoutconsidering protrusions 80E) of the cap 14. In addition, side surface51, as shown in FIG. 9, extends arcuately between the base and the uppertopography 61 of cap 14. Side surface 51 may extend in a generallytapered or conical fashion, may exhibit a radius or other arcuate shape,or may otherwise transition between a cross section of the base of theaccess port to a cross section proximate the upper topography 61Cthereof.

Further, FIG. 10 shows an embodiment of a cap 14 for forming an accessport contemplated by the instant disclosure having an upper topography61C thereof comprising alternating circumferentially extendingprotrusions 80E and circumferentially extending recesses 82, wherein thecircumferentially extending protrusions 80E are circumferentially largerthan the circumferentially extending recesses 80E. In another embodimentof an access port contemplated by the instant disclosure, FIG. 11 showsa perspective view of a cap 14 having an upper topography 61C thereofcomprising alternating circumferentially extending protrusions 80E andcircumferentially extending recesses 82, wherein the circumferentiallyextending protrusions 80E and the circumferentially extending recesses82 are substantially equal in (circumferential) sized or extension. Inyet a further embodiment of a cap 14 for forming an access portcontemplated by the instant disclosure, FIG. 12 shows a perspective viewof a cap 14 having an upper topography 61C thereof comprising threecircumferentially extending protrusions 80E and three circumferentiallyextending recesses 82, arranged so as to alternate circumferentially,wherein the circumferentially extending protrusions 80E and thecircumferentially extending recesses 82 are substantially equal in(circumferential) size.

FIG. 13 shows a perspective view of an additional embodiment of an cap14 for forming an access port contemplated by the instant disclosureincluding an upper topography 61C including circumferentially extendingprotrusions 80T and circumferentially extending recesses 82T, whereintransition regions 81 are provided between circumferentially extendingprotrusions 80T and circumferentially extending recesses 82T. Suchtransition regions 81, as shown in FIG. 13, may taper or generallysmoothly transition between a circumferentially extending protrusion 80Tand a circumferentially extending recess 82T. Also, FIG. 14 shows aperspective view of an additional embodiment of a cap 14 for forming anaccess port contemplated by the instant disclosure including an uppertopography 61C including protrusion regions 96 and recessed regions 98that transition between one another and alternate circumferentially soas to form an undulating topography comprising upper topography 61C.Such an undulating topography, as shown in FIG. 14, generally smoothlytransitions between circumferentially adjacent protrusion regions 96 andrecessed regions 98.

In a further embodiment of an access port contemplated by the instantdisclosure, FIGS. 15A and 15B show a perspective view and a topelevation view, respectively, of an access port 10 generally configuredas is described with reference to FIG. 5 but may include at least onenonplanar side surface. In another embodiment, access port 10 as shownin FIG. 15 may be configured as shown in FIGS. 1-4 or FIGS. 6-7, or anyembodiments described hereinbelow, without limitation. Morespecifically, elongated body 20 of access port 10, as shown in FIGS. 15Aand 15B, includes three side surfaces 50R that extend arcuately (asshown in FIG. 15B). Such a configuration may provide an access port 10that is identifiable subsequent to implantation. In yet anotherembodiment of an access port contemplated by the instant disclosure,FIG. 16 shows a perspective view of an access port 10 including a sidewall 100 that truncates a portion of a radius 32 formed between sidesurfaces 50 of access port 10. It may also be noted that such an accessport 10 may include three suture apertures 66, which may, taken alone orin combination with at least one other feature, comprise at least oneidentifiable feature of an access port contemplated by the instantdisclosure. In addition, as shown in FIG. 16, outlet stem 31 may extendfrom side wall 100.

In a further embodiment of an access port contemplated by the instantdisclosure, FIG. 17 shows a perspective view of an access port 10wherein cap 14 and base 16, when assembled to one another along matingline 15, form a flange feature or lip feature 102 that extends about atleast a portion of the periphery of the access port 10. As shown in FIG.17, lip feature 102 extends substantially about the periphery of theaccess port 10, proximate to the mating line 15 between cap 14 and base16. Such a feature may comprise at least one identifiable feature of anaccess port contemplated by the instant disclosure. Thus, it may beappreciated that a peripheral discontinuity between the cap 14 and base16 may be formed generally along the mating line 15 therebetween. In theembodiment of an access port as shown in FIG. 7, an overhanging rimfeature 76 may comprise a peripheral discontinuity or, in the embodimentof an access port as shown in FIG. 17, a lip feature 102 may comprise aperipheral discontinuity.

In a further embodiment of an access port contemplated by the instantdisclosure, FIG. 18 shows a perspective view of an access port 10wherein at least a portion of at least one side surface 50 is concave.As shown in FIG. 18, concave region 106 of side surface 50 is concave.Concavity (i.e., a concave region 106) may be exhibited over at least aportion of a side surface of an access port of any of the embodiments asshown herein, without limitation. Thus, at least one side surface 50 ofan access port contemplated by the instant disclosure having at least atleast a portion thereof that is concave is one exemplary example of atleast one perceivable feature for identification of an access portcontemplated by the instant disclosure.

In a further embodiment of an access port contemplated by the instantdisclosure, FIG. 18 shows a perspective view of an access port 10wherein at least a portion of at least one side surface 50 is concave.As shown in FIG. 18, region 106 of side surface 50 is concave. Concavitymay be exhibited over at least a portion of a side surface of an accessport of any of the embodiments as shown herein, without limitation.Thus, at least one side surface 50 of an access port contemplated by theinstant disclosure having at least at least a portion thereof that isconcave is one exemplary example of at least one perceivable feature foridentification of an access port contemplated by the instant disclosure.

In a further embodiment of an access port contemplated by the instantdisclosure, FIG. 19 shows a perspective view of an access port 10generally configured as is described with reference to FIGS. 6A and 6B.More specifically, elongated body 20ER, as shown in FIG. 19 includes aside surface 50ER that extends arcuately from upper topography 61 ofaccess port 10 downwardly (i.e., toward reference plane 11 as shown inFIGS. 1A and 1B). Such a configuration may provide an elongated body 20Eof an access port 10 having an elongated side portion.

It should be understood from the above-described various embodiments ofan access port contemplated by the instant disclosure that manyvariations, additions, or different features may be encompassed by theinstant disclosure. Thus, the instant disclosure is not limited to theseveral above-described exemplary embodiments.

For example, as shown in FIG. 20, which shows a top elevation view of anaccess port 10 contemplated by the instant disclosure, an access port 10may include a side wall 100 that at least partially truncates a radius32 between side surfaces 50, outlet stem 31 extending from side wall100, and at least one of a concave region 106 and an arcuate surface50R. Further, as shown in FIG. 20, suture apertures 66 may be positionedso as to identify the access port 10 after subcutaneous implantation.

Additionally, the instant disclosure contemplates access ports having anexterior geometry that is polygonal in nature. Specifically, the instantdisclosure contemplates that an access port contemplated by the instantdisclosure may exhibit a generally triangular exterior. Thus, as shownin FIG. 21, body 20 may exhibit a generally pyramidal or tapered shape(i.e., a polygonal base having surfaces for each side of the polygonextending toward a common vertex). Generally, a body 20T of an accessport 10 may extend between a generally triangularly-shaped base and arelatively smaller, generally triangularly-shaped upper base.Accordingly, the exterior of access port 10 may be substantially definedby three side surfaces (e.g., 50, 50R, 102, 50E) having radiuses 32extending therebetween. In addition, the upper topography 61 of accessport 10 may be defined by upper surface 60 in combination with sideregions 54 and rounded corner regions 30. Such a configuration mayprovide an access port having at least one feature that may be perceivedby palpation.

FIGS. 22 and 23 show a perspective view and a top elevation view ofanother embodiment of an access port including a generally triangularexterior geometry. More particularly, as shown in FIGS. 22 and 23, a cap14 and base 16 (collectively forming a housing) may capture a septum 118to form an access port 10. Further, outlet stem 31 may include a stembase that may be positioned within and sealed to an outlet recess 93formed within base 16. The outlet stem 31 may be in fluid communicationwith a cavity formed within the access port 10. Optionally, suture plugs89 may be positioned within suture cavities 91 formed in base 16. Sutureplugs 89 may comprise a pliant material (e.g., silicone, rubber, etc.)that may provide some resilience between sutures coupling the accessport 10 (i.e., the base 16) to a patient. In further detail, a sideperiphery 95 (e.g., one or more side walls) of access port 10 may begenerally triangular. Thus, cap 14 and base 16 may collectively form agenerally triangular housing or body of access port 10. Also, theinstant disclosure contemplates that side periphery 95 may increase ordecrease in cross-sectional size (e.g., by tapering or arcuatelytransforming) between upper surface 161 of cap 14 and lower surface 151of base 16. As shown in FIGS. 22 and 23, a transverse cross section(taken in a selected plane substantially parallel to lower surface 151of base 16) of access port 10 may be larger proximate to lower surface151 of base 16 and may be relatively smaller proximate upper surface 161of cap 14.

Additionally, FIG. 24 shows a simplified representation of a transversecross section of access port 10. As shown in FIG. 24, side periphery 95of access port 10 may define three side regions 103 that extend betweenassociated vertex regions 101. In addition, in one embodiment and asshown in FIG. 24, side periphery 95 may define a substantiallyequilateral generally triangular shape. As one of ordinary skill in theart will appreciate, side regions 103 may arcuately extend betweenassociated vertex regions 101; thus, side regions 103 may form “sides”of a generally triangular shape. Further, although vertex regions 101are rounded, it may be appreciated that such vertex regions 101 form anintersection between adjacent side regions 103. Accordingly, one ofordinary skill in the art will appreciate that the phrase “generallytriangular,” as used herein, encompasses any generally three-sidedgeometry wherein adjacent sides intersect, without limitation. Forexample, the phrase “generally triangular” encompasses three sidedpolygons, circular triangles, equilateral triangles, etc., withoutlimitation.

The instant disclosure also contemplates that at least one feature of anaccess port contemplated by the instant disclosure may not be observablevisually or by palpation but, rather, may be otherwise observable. Forexample, the instant disclosure contemplates that at least one featureof an access port may be observable through interaction with an imagingtechnology such as x-ray or ultrasound. For example, in one embodiment,a metal feature (e.g., a plate or other metal geometry) may be includedby an access port contemplated by the instant disclosure. As may beappreciated, such a metal feature may be represented on an x-raygenerated by exposure of the access port to x-ray energy whilesimultaneously exposing x-ray sensitive film to x-ray energy passingthrough the access port. Further, the instant disclosure contemplatesthat a size, shape, or both size and shape of a metal feature of anaccess port may be configured for enhancing identification of an accessport. For example, assuming that a metal feature comprises a metalplate, a size, shape, or both may be selectively tailored foridentification of an access port. Similarly, a feature of an access portcontemplated by the instant disclosure may be tailored for detection viaultrasound interaction. Such a feature may comprise an exteriortopographical feature. In another embodiment, such a feature maycomprise a composite structure including two or more materials that forman interface surface that may be identified by ultrasound imaging.

One example embodiment of a feature observable through interaction withimaging technology contemplated by the instant disclosure is shown inFIGS. 52, 53A, and 53B. FIG. 52 depicts a bottom perspective view of anaccess port 10. FIG. 53A shows a top view of the access port 10, whileFIG. 53B shows a bottom view of the access port. The access port 10 ofFIGS. 52, 53A, and 53B is similar in some respects to the access port 10as seen in FIGS. 22 and 23, including a cap 14 and a base 16 thatcooperate to define a body. In the present example embodiment, however,the lower surface 151 of the base 16 includes an identification feature200, as seen in FIGS. 52 and 53B. It is contemplated that theidentification feature 200 can be one or more alphanumeric characters,such as the “CT” depicted. Additionally, the instant disclosurecontemplates the use of other markings, such as one or more symbols,patterns, characters, designs, a combination thereof, etc. Theidentification feature 200 can be of any size, shape, or both in orderto tailor the identification feature for the specific identification ofone or more of a variety of characteristics of the access port.Specifically, in one embodiment the identification feature 200 canconvey information to a practitioner regarding the power-injectabilityof the implanted access port. Note that in the present embodiment, theidentification feature 200 is defined as a recessed feature, whereas inother embodiments the identification feature may be defined in otherways, as discussed hereafter.

As mentioned above, FIG. 53A depicts a top view of the access port 10.Note that the identification feature 200 is not observable through theupper surface 161 of the cap 14 or through the septum 118 without theinteraction of imaging technology. As seen in FIG. 53B, the alphanumericcharacters of the identification feature 200, “CT,” are engravedmirror-reversed on the lower surface 151 of the base 16. The “CT” isengraved mirror-reversed so that when imaging technology, such as x-rayimaging, is used to identify a subcutaneously implanted access port, the“CT” will be visible in the proper orientation. By engraving a desiredidentification feature mirror-reversed on the bottom surface of anaccess port, a practitioner will be able to determine if there is aproblem with the port after implantation, such as if the access port hasflipped or otherwise become mis-oriented while in the body of thepatient. Thus, if the identification feature is seen mirror-reversed oraskew in an x-ray image, the practitioner can correct the problem beforeattempts are made to use the access port.

Although also useful in access ports where only a portion of a portincludes a metallic material, e.g., a metal plate, the engravingtechnique is well-suited in one embodiment for access ports that arecomposed of solid metal, such as titanium, stainless steel, or othermaterials that are typically radiopaque, i.e., non-transmissive tox-rays in sufficient thickness. FIGS. 54A-54C are representative imagesof the access port 10 of FIG. 52, which includes titanium or othermetallic material, as seen via x-ray imaging after implantation into thepatient. The access port 10 includes the identification feature 200 asseen in FIGS. 52 and 53B. Due to the relative thickness of the accessport 10, the material of the base 16 and cap 14 surrounding a cavityperiphery 36A of the cavity 36, which is a fluid cavity, issubstantially non-transmissive to x-rays and therefore appearsrelatively dark in the x-ray image of FIG. 54A. However, the material ofthe access port 10 within the cavity periphery 36A is relatively thinnerthrough a cavity base 220 (as seen in FIG. 55) than through the materialof the cap 14 and base 16. Thus, additional thinning of the materialwhen creating the identification feature 200 enables the identificationfeature to appear relatively more radiographically transmissive than thesurrounding material of the cavity base under x-ray imaging. Note thatthe identification feature 200 in FIG. 54A is visible in the properorientation, indicating that the access port is not flipped.

FIGS. 54B and 54C are additional representative x-ray images of theidentification feature 200 of the access port 10, wherein the accessport is tilted at angles of approximately 20 and 50 degrees,respectively. Thus, the identification feature 200 is also useful fordetermining relative orientation of the access port 10 afterimplantation.

FIG. 55 shows a cross-sectional view taken at line 55-55 of the accessport 10 in FIG. 52. In this example embodiment, the identificationfeature 200 is disposed beneath the septum 118 and the cavity 36. FIGS.56A and 56B further depict enlarged cross-sectional views of potentialcut profiles of the recessed identification feature 200. FIG. 56A showsa rounded engraving profile 201, engraved on the lower surface 151 ofthe base 16 and used for purposes of aesthetics and ease ofmanufacturing. For a relatively more defined contrast under imagingtechnology, however, a sharp-edged engraving profile 202 may be used, asseen in FIG. 56B. Note that a variety of cross-sectional recessedprofiles may be employed. This disclosure further contemplates thatalthough engraving is discussed here, other methods of marking theidentification feature may be used, such as milling, machining, chemicalor laser etching, molding, stamping, etc.

Regardless of the cut profile used, better contrast is achievedgenerally with greater engraving depth X. The optimal engraving depth Xwill depend, however, on the thickness of the overall cavity base 220,which is the portion of the base directly below the cavity 36, as shownin FIG. 55. For example, in an embodiment of an access port includingtitanium, if the overall thickness of the cavity base 220 isapproximately 0.020″ then sufficient contrast for x-ray imaging purposescan be obtained in one embodiment by engraving the identificationfeature 200 to a depth X (FIGS. 56A, 56B) of between about 0.009″ andabout 0.011″. In another example embodiment of an access port includingtitanium, where the overall thickness of the cavity base 220 isapproximately 0.030″, sufficient contrast can be obtained by engravingthe identification feature 200 to a depth X of between about 0.015″ andabout 0.021″. One of ordinary skill in the art will appreciate that thedepth of an engraved identification feature can be varied substantiallyin order to comply with a product's safety requirements and still remainwithin the scope contemplated by this disclosure. In addition, the depthX of the identification feature can vary according to the position ofthe feature on the access port, the thickness of material to bepenetrated by the imaging technology, the type of material included inthe access port, etc.

It is also contemplated by this disclosure that the use of anidentification feature in a metallic or other radiopaque access port canbe applied to access ports having a variety of possible configurations,such as is seen in FIGS. 57A-58C, for example. FIGS. 57A-57C depict oneembodiment, wherein the access port 10 includes an identificationfeature 200 on a lower surface 251 of a base or body 116. The accessport 10 in FIGS. 57A-57C includes a retaining ring 230, which seals theseptum 118 to the base or body 116, over the cavity 36. In oneembodiment, the retaining ring 230 is press fit into the base or body116 to hold the septum 118 in place. FIGS. 58A-58C show yet anotherembodiment, wherein the access port 10 includes an identificationfeature 200 on the cavity base 220 and wherein the cavity base is matedto and flush with a lower surface 252 of a cap 114 to define a body. Ina particular embodiment, the cavity base 220 is press fit into the cap114, though other mating configurations can also be employed.

In another embodiment contemplated by the instant disclosure, FIGS. 59Aand 59B show that the location of the identification feature 200 canvary as well. Rather than placing the identification feature 200 underthe cavity 36, it is possible to place the identification feature underanother portion of the access port 10, such as under the outlet stem 31and between the septum plugs 89, i.e., proximate the outer periphery ofthe access port bottom surface. Though the overall thickness of theaccess port structure above the identification feature 200 is greater inthis location than if engraved under the cavity 36, the change inlocation allows for a relatively deeper engraving, which will increasecontrast without risk of excessive thinning of the cavity base 220.Additionally, in one embodiment, it is possible to define theidentification feature compositely by engraving into both the bottom andtop surfaces, such that the engravings are vertically aligned. Thisenables the remaining material thickness to be substantially reduced inorder to provide relatively greater radiographic transmission throughthe identification feature.

Additionally, the instant disclosure contemplates access ports havingany variety or combination of desired identification features forindicating power-injectability or other aspect or characteristic of anaccess port. Specifically, FIGS. 60A-61B depict different types ofidentification features 200, according to example embodiments. FIGS.60A-60B depict a symbolic identification feature 200. FIGS. 61A-61Bdepict an exemplary embodiment of an access port 10 including acombination of identification features 200, namely an alphanumericidentification feature 200A and a patterned identification feature 200B.A patterned or symbolic identification feature can also be used to helpindicate the orientation of the port or for any other desired reason. Itis understood by the instant disclosure that other symbols, patterns,marks, and alphanumeric characters can be used both alone and in anycombination with each other on a variety of access port configurations.

In additional embodiments, the identification feature can be defined onan inside bottom surface 36B of the cavity 36 of an access port 10, orin addition to the identification feature 200 provided on the bottomsurface 251. In another embodiment, the material surrounding thedefining edges of the desired radiopaque alphanumeric character, symbol,pattern, etc., can be removed instead of removing the desired featureshape itself so as to define a “positive” relief image of theidentification feature. Such a positive relief identification featurecan be defined on a lower surface of an access port body or on theinside bottom surface of the cavity, for example.

In addition to the various types of symbols, patterns, marks, andalphanumeric characters that are contemplated by the instant disclosure,FIGS. 62A-63C disclose additional example embodiments of identifyingfeatures on access ports that are observable via x-ray or other suitableimaging technology. Specifically, the instant disclosure contemplatesthe use of shelled-out cavities 204, wherein portions of the access port10 are hollowed out. This results in shelled-out cavities 204 extendinginward from the lower surface 251 of the base or body 116 orcorresponding port lower surfaces of the other embodiments describedherein, including the lower surface 151 of the base 16, as in FIG. 151,and the lower surface 252 of a cap 114, as in FIGS. 58A-58C. This isdone by removing the material surrounding the cavity 36 withoutdisrupting the cavity periphery 36A or the outer side surfaces 250 ofthe access port 10. As seen in FIG. 62B, ribs 240 may be left to supportthe remaining “shelled” frame of the access port 10. The definition ofsuch cavities 204 provides a relative difference in radiopacity of theaccess port 10 that can be identified via x-ray imaging. As such, thecavities 204 can be arranged to define a pattern or to form an indiciafor identification of an aspect or characteristic of the access port 10.Note that in other embodiments, the cavities can be defined so as toextend from other surfaces of the access port, including the top andsides thereof.

In a further aspect contemplated by the instant disclosure, it iscontemplated that a communicative technology may be utilized whereininformation is encompassed by an access port contemplated by the instantdisclosure. Generally, a communication device (e.g., a radio beacon, alight-emitting element, an ultrasound emitting transducer, etc.), may beimbedded or otherwise affixed to an access port contemplated by theinstant disclosure. Such a communication device may be configured fortransmitting information in response to a given impetus. Morespecifically, the instant disclosure contemplates that an access portcontemplated by the instant disclosure may be exposed to a requestsignal (e.g., a sound, an impact or an acceleration, light, radio waves,etc.). Such a request signal may cause the communication device totransmit information therefrom via sound, light, radio waves, or asotherwise known in the art. Such information may be employed foridentifying an access port contemplated by the instant disclosure.

In one exemplary example, it is contemplated that radio frequencyidentification technology may be employed for identification of anaccess port contemplated by the instant disclosure. Particularly,so-called active RFID tags are powered by an internal battery and aretypically read/write devices. Currently, a suitable cell coupled tosuitable low power circuitry can ensure functionality for as long as tenor more years, depending upon the operating temperatures and read/writecycles and usage. So-called passive RFID tags operate without a separateexternal power source and obtain operating power generated from thereader. Passive RFID tags are typically programmed with a unique set ofdata (usually 32 to 128 bits) that cannot be modified. Read-only tagsmay operate as an identifier comparable to linear barcodes which maycontain selected product-specific information. Thus, passive RFID tagsmay be much lighter than active RFID tags, less expensive, and may offera virtually unlimited operational lifetime. The tradeoff is that theyhave shorter read ranges than active tags and require a higher-poweredreader.

One advantage of RFID approach is the noncontact, non-line-of-sightnature of the technology. Tags can be read through a variety ofsubstances such as snow, fog, ice, paint, crusted grime, and othervisually and environmentally challenging conditions, where otheroptically read technologies may be less effective. RFID tags can also beread in challenging circumstances at rapid speeds, in most casesresponding in less than about 100 milliseconds.

While certain representative embodiments and details have been shown forpurposes of illustrating aspects contemplated by the instant disclosure,it will be apparent to those skilled in the art that various changes inthe methods and apparatus disclosed herein may be made without departingform the scope contemplated by the instant disclosure, which is definedin the appended claims. For example, other access port sizes and shapesmay be employed; and various other embodiments and structures may beemployed for forming at least one identifiable feature of an access portcontemplated by the instant disclosure. In particular, FIGS. 25-51illustrate a number of additional exemplary embodiments of access port10. As is apparent from these figures, access port 10 may be formed inany number of shapes and sizes, such that any number of modificationsand changes are possible to any of the embodiments described andillustrated herein without departing from the spirit and scope of theinstant disclosure.

1. A method of making an access port for providing subcutaneous accessto a patient, comprising: providing a metallic body defining a fluidcavity accessible by inserting a needle through a septum; and creating arecessed identification feature in a bottom surface of the metallicbody, the recessed identification feature observable via x-ray imagingtechnology subsequent to subcutaneous implantation of the access port,the recessed identification feature identifying the access port as apower-injectable port.
 2. The method according to claim 1, wherein thecreating step includes utilizing a marking method selected from thegroup consisting of: engraving, milling, machining, chemical etching,laser etching, molding, stamping, and combinations thereof.
 3. Themethod according to claim 1, wherein the bottom surface is an externalsurface of the metallic body.
 4. The method according to claim 1,wherein the bottom surface is an internal surface of the fluid cavity.5. The method according to claim 1, wherein the recessed identificationfeature includes one or more alphanumeric characters.
 6. The methodaccording to claim 5, wherein the one or more alphanumeric charactersincludes the letters “C” and “T.”
 7. The method according to claim 1,wherein the recessed identification feature indicates an orientation ofthe access port when the access port is imaged by x-ray imagingtechnology.
 8. The method according to claim 1, wherein the recessedidentification feature is created below the fluid cavity, and is boundby an outer perimeter of the fluid cavity.
 9. The method according toclaim 1, wherein the provided metallic body comprises titanium.
 10. Themethod according to claim 9, wherein the created recessed identificationfeature has a depth in the range of about 0.009 inch to about 0.011 inchwhen the thickness of the bottom surface is about 0.020 inch.
 11. Themethod according to claim 9, wherein the created recessed identificationfeature has a depth in the range of about 0.015 inch to about 0.021 inchwhen the thickness of the bottom surface is about 0.030 inch.
 12. Themethod according to claim 1, wherein the providing step includes:providing a metallic base defining the fluid cavity; and coupling a capto the base such that a septum is disposed between the cap and the base,and the septum is accessible through an opening in the cap.
 13. Themethod according to claim 13, wherein the bottom surface is an externalsurface of the base.
 14. The method according to claim 14, wherein thecoupling step includes press-fitting the base into the cap such that theexternal surface of the base is flush with a lower surface of the cap.15. The method according to claim 1, wherein the recessed identificationfeature is created below an outlet stem of the port, outside an outerperimeter of the fluid cavity.
 16. The method according to claim 15,further comprising creating a second recessed identification feature ina top surface of the metallic body such that the second recessedidentification is vertically aligned with the first recessedidentification feature.
 17. The method according to claim 15, whereinthe recessed identification feature includes one or more alphanumericcharacters.
 18. The method according to claim 17, wherein the one ormore alphanumeric characters includes the letters “C” and “T.”